Clinical Trial: Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Bromocriptine on LV Function in Women With Peripartum Cardiomyopathy A Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Bromocriptine
Brief Summary: This is a randomized, controlled clinical trial to evaluate the efficacy and safety of bromocriptine for improvement of left ventricular function of women with Peripartum cardiomyopathy (PPCM). A Multi center trial in Germany.
Detailed Summary:
Peripartum cardiomyopathy (PPCM) is a serious life threatening heart disease of unknown etiology in previously healthy women. Only a minority of patients recovers completely while the majority of PPCM patients develop persistent ventricular dysfunction and may experience severe heart failure leading to cardiac transplantation. Thus, these young patients are very sick at a time when the newborn would need a healthy mother. Many of PPCM patients need lifelong treatment causing a large financial and social burden. Indeed, a better understanding of the disease and more efficient therapeutic options are urgently needed. To date, no specific therapy is available so that patients are treated by medical pharmacotherapy for heart failure.
Diagnosis of PPCM is usually made at advanced stages of the disease in severely symptomatic women but prognosis of affected women is poor with reported mortality rates of 15% and recovery in only 23% to 54% of PPCM patients despite optimal medical treatment. Therefore strategies are urgently needed to identify patients at risk and novel therapeutic approaches are required to improve poor prognosis of affected women.
The trial would establish a new specific therapeutic regimen for PPCM and the investigators can expect that such a novel approach would be rapidly adopted in the clinical management of this disease. Since the trial design follows state-of the-art guidelines, the investigators assume that bromocriptine would shortly be adopted into clinical guidelines of the German Cardiac Society, European Cardiac Society, and the American Heart Association.
Sponsor: Hannover Medical School
Current Primary Outcome: Change in left ventricular ejection fraction (LVEF) from baseline to six months follow-up as assessed by cardiac Magnetic Resonance Imaging (MRI) & Echocardiography [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Combined endpoint of hospitalization for heart failure, eligibility for cardiac transplantation, cardiac transplantation, and mortality during 6 months follow-up; individual components of the combined endpoint; adverse events [ Time Frame: 6 Months ]
Original Secondary Outcome: Same as current
Information By: Hannover Medical School
Dates:
Date Received: October 19, 2009
Date Started: June 2010
Date Completion:
Last Updated: November 17, 2016
Last Verified: November 2016
